Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial "AMASCIS-01"

Recruiting

Phase 2 Results N/A

Trial Description

Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients

Detailed Description

20 Patients presenting with a moderate-severe acute ischemic stroke who will be randomized in a 1:1 proportion to intravenous treatment with allogeneic stem cells from adipose tissue or to placebo (vehicle).

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: In patients randomly assigned to the placebo arm will receive a intravenous solution (containing the vehicle) with the same appearance as the drug under investigation. It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.
  • Allogenic mesenchymal stem cells from adipose tissue Drug
    ARM 1: Kind: Experimental
    Label: Allogeneic stem cells from adipose tissue
    Description: The experimental drug is a solution of mesenchymal stem cells from adipose tissue. It will be administered as a single intravenous dose within the first two weeks after the onset of stroke symptoms.Dose: 1 million units/kg

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety 24 months Yes
Secondary Efficacy 3 months No
Primary Number of participants with Adverse events, complications. 24 months Yes

Sponsors